Tirzepatide Effects on Coronary Plaque in Overweight People With Heart Disease
Tests tirzepatide against placebo in adults with overweight and coronary artery disease.
Plain-language title generated from the registry record
Registry title: The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
Key facts
- Where
- Copenhagen Oe and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 4
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tina Vilsbøll
- Trial code
- NCT06606821EU 2023-505270-15-00
- Record updated
- 22 May 2025
- Original description
The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.Read full original descriptionShow less
The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People With Coronary Disease - The IDEAL-COR Study
The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.
Inclusion: Informed written consent; BMI equal to or above 27 kg/m2; Age 18 years or older; Referred to coronary angiogram (CAG) due to stable angina; Coronary atheromatosis by angiography (obstructive or non-obstructive); LCBI4mm >200 by NIRS in a vessel not subjected to coronary intervention.
Exclusion: Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA); History of coronary artery bypass surgery (CABG); Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation; History of heart failure New York Heart Association (NYHA) class III or IV; History of pancreatitis or plasma amylase >2 times upper normal limit; Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC); Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients; Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery; History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline; Left ventricular ejection fraction (LVEF) ≤35%; eGFR <30 ml/min/1.53 m2; Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal); Pregnancy, planned pregnancy or breastfeeding; Left main stenosis (≥50% diameter or haemodynamically significant); Chronic total occlusion of any major coronary vessel; Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention.